Roche trials database

Trial information

A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With MabThera/Rituxan (Rituximab) Plus Chemotherapy Followed by GA101 or MabThera/Rituxan Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)

Status:

Recruiting

Protocol number:

BO21223

Sponsor:

Hoffmann-La Roche

Co-sponsors:

• UK National Cancer Research Institute (NCRI)
• German Low-Grade Lymphoma Study Group (GLSG)

Company division:

Pharmaceutical

Official Scientific Title:

A multicentre, phase III, open label, randomized study in previously untreated patients with advanced indolent non-Hodgkin's lymphoma evaluating the benefit of GA101 (RO5072759) + chemotherapy compared to Rituximab + chemotherapy followed by GA101 or Rituximab maintenance therapy in responders.

Brief summary:

This open-label, randomized study will assess the efficacy and safety of obinutuzumab (RO5072759) in combination with chemotherapy compared to MabThera/Rituxan (rituximab) with chemotherapy followed by obinutuzumab or MabThera/Rituxan maintenance in patients with untreated advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, patients achieving response (CR or PR) will go on to a maintenance period thereby continuing on their randomized antibody treatment alone every 2 months until disease progression for a total of 2 years. Anticipated time on study treatment is up to approximately 2.5 years. After maintenance or observation patients will be followed for 5 years until progression. After progression, patients will be followed for new anti-lymphoma therapy and overall survival until the end of the study. Target sample size is 1400.

Study phase:

III

Study type:

Interventional; Treatment; Randomized; Parallel; Safety/efficacy study

Conditions:

• Non-Hodgkin's Lymphoma

Intervention type:

Drug

Intervention name:

RO5072759 [GA101]

Primary outcome:

1. Progression-free survival in patients with follicular lymphoma, investigator-assessed according to the Revised Response Criteria for Malignant Lymphoma Time frame: up to approximately 7.5 years

Key secondary outcomes:

1. Progression-free survival in the overall study population, investigator-assessed Time frame: up to approximately 7.5 years
2. Progression-free survival, Independent Review Committee - assessed Time frame: up to approximately 7.5 years
3. Response (overall response and complete response), investigator-assessed Time frame: 168 days
4. Response (overall response and complete response), Independent Review Committee - assessed Time frame: 168 days
5. Overall survival Time frame: up to approximately 10.7 years
6. Event-free survival Time frame: up to approximately 7.5 years
7. Disease-free survival Time frame: up to approximately 7.5 years
8. Duration of response Time frame: up to approximately 7.5 years
9. Time to next anti-lymphoma treatment Time frame: up to approximately 10.7 years
10. Safety: Incidence of adverse events Time frame: up to approximately 10.7 years
11. Patient-reported outcomes (Functional Assessment of Cancer Therapy for Lymphoma scale, EuroQol EQ-5D questionnaire) Time frame: up to approximately 7.5 years
12. Medical resource utilization (hospitalizations, subsequent drug therapies, medical and surgical procedures) Time frame: up to approximately 7.5 years

Inclusion criteria:

• Adult patients, >/= 18 years of age
• CD20-positive indolent B-cell non-Hodgkin's lymphoma (follicular lymphoma or splenic, nodal or extranodal marginal zone lymphoma)
• Stage III or IV disease, or Stage II bulky disease (defined as tumour diameter >/= 7 cm), requiring treatment
• For patients with follicular lymphoma: requirement for treatment according to GELF criteria
• For patients with symptomatic marginal zone lymphoma: disease that is de novo or has relapsed following local therapy (i.e. surgery or radiotherapy) and requires therapy as assessed by the investigator
• At least one bi-dimensionally measurable lesion (>2 cm in its largest dimension by CT scan or MRI)
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
• Adequate hematologic function

Exclusion criteria:

• Central nervous system lymphoma, leptomeningeal lymphoma, or histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
• Grade 3b follicular lymphoma, small lymphocytic lymphoma or Waldenström's macroglobulinaemia
• Ann Arbor Stage I disease
• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy, known hypersensitivity to any of the study drugs or sensitivity to murine products, or history of sensitivity to mannitol
• For patients with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma with chemotherapy, immunotherapy, or radiotherapy
• For patients with non-follicular lymphoma: prior treatment with chemotherapy or immunotherapy
• Regular treatment with corticosteroids during the 4 weeks prior to the start of Cycle 1
• Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
• For patients who will be receiving CHOP: LVEF <50% by MUGA scan or echocardiogram
• History of prior malignancy with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix
• Known active infection, or major episode of infection within 4 week prior to the start of Cycle 1
• Vaccination with a live vaccine within 28 days prior to randomization
• Recent major surgery (within 4 weeks prior to start of Cycle 1), other than for diagnosis
• Abnormal laboratory values as defined by protocol for creatinine, creatinine clearance, AST or ALT, total bilirubin, INR, PTT or aPPT, unless these abnormalities are due to underlying lymphoma
• Positive as per protocol definition for HIV, HTLV1, hepatitis C or chronic hepatitis B
• Pregnant or lactating women
• Life expectancy < 12 months
• Participation in another clinical trial with drug intervention within 28 days prior to start of Cycle 1 and during study

Gender:

Males or Females

Age limits:

Min: 18 years Max: N/A (No limit)

Accepts healthy volunteers:

No

Anticipated start date:

July, 2011

Trial registration date:

01.02.2011

Date last updated:

06.05.2013

This trial is being conducted at the following locations:

Australia

• EAST MELBOURNE
• MELBOURNE
• PERTH
• SYDNEY
• WOOLLOONGABBA

AUSTRALIA

• FITZROY, Victo

Belgium

• GENT
• KORTRIJK
• LEUVEN

Brazil

• CAMPINAS
• FLORIANOPOLIS
• PORTO ALEGRE
• SAO PAULO
• SÃO PAULO

Canada

• CALGARY, AB
• EDMONTON, AB
• MONCTON, NB
• EAST YORK, ON
• OTTAWA, ON
• TORONTO, ON
• GREENFIELD PARK, QC

China

• BEIJING
• CHANGCHUN
• FUZHOU
• GUANGZHOU
• HARBIN
• NANJING
• SHANGHAI
• SHENYANG
• SUZHOU
• WUHAN

Czech Republic

• BRNO
• PRAHA 2

CZECH REPUBLIC

• Hradec Kralove

Finland

• HELSINKI
• TAMPERE

France

• ANGERS
• BREST
• CLERMONT-FERRAND
• LEMANS
• MARSEILLE
• MONTPELLIER
• PERPIGNAN

Germany

• AMBERG
• BERLIN
• BREMEN
• CHEMNITZ
• DESSAU
• DRESDEN
• ERFURT
• ESCHWEILER
• FRANKFURT
• FREIBURG
• GÖTTINGEN
• GREIFSWALD
• HAGEN
• HANNOVER
• HEIDELBERG
• HOF
• HOMBURG/SAAR
• IDAR-OBERSTEIN
• JENA
• KIEL
• KOBLENZ
• LANDSHUT
• LEBACH
• LEIPZIG
• LUDWIGSHAFEN
• MAGDEBURG
• MAGEDBURG
• MAINZ
• MANNHEIM
• MÖNCHENGLADBACH
• MUENCHEN
• MÜNCHEN
• MÜNSTER
• MUTLANGEN
• NEUNKIRCHEN/SAAR
• NORTHEIM
• OLDENBURG
• PADERBORN
• RECKLINGHAUSEN
• REGENSBURG
• SAARBRUECKEN
• STADE
• STUTTGART
• TRIER
• TÜBINGEN
• ULM
• WIESBADEN
• WÜRZBURG

GERMANY

• Köln

Hungary

• BUDAPEST
• DEBRECEN
• GYOR
• KAPOSVAR
• PECS
• SZEGED

Israel

• HAIFA
• JERUSALEM
• PETACH TIKVA
• RAMAT GAN

Italy

• BERGAMO
• MILANO
• MODENA
• PADOVA
• ROMA
• ROZZANO

Japan

• AICHI
• AOMORI
• CHIBA
• EHIME
• FUKUOKA
• GUNMA
• HIROSHIMA
• HYOGO
• KANAGAWA
• KUMAMOTO
• KYOTO
• MIYAGI
• NAGANO
• NIIGATA
• OSAKA
• TOCHIGI
• TOKYO

Russian Federation

• NIZHNY NOVGOROD

RUSSIAN FEDERATION

• MOSCOW
• Petrozavodsk

Spain

• ALCORCON
• BADALONA
• BILBAO
• MADRID
• SABADELL

Sweden

• GÖTEBORG
• STOCKHOLM

Taiwan

• TAIPEI
• TAOYUAN

U.S.A.

• FAYETTEVILLE, AR
• ORANGE, CA
• SIOUX CITY, IA
• POST FALLS, ID
• GALESBURG, IL
• MAYWOOD, IL
• WESTWOOD, KS
• SPRINGFIELD, MO
• MISSOULA, MT
• FARMINGTON, NM
• PORTLAND, OR
• TACOMA, WA

United Kingdom

• ABERDEEN
• BIRMINGHAM
• BOURNEMOUTH
• BRISTOL
• CAMBRIDGE
• CANTERBURY
• CARDIFF
• COTTINGHAM
• EDINBURGH
• GLASGOW
• GREAT YARMOUTH
• HARLOW
• LEEDS
• LEICESTER
• LONDON
• MANCHESTER
• NORWICH
• NOTTINGHAM
• OXFORD
• PORTSMOUTH
• SOUTHAMPTON
• SUTTON
• SWANSEA
• SWINDON
• TRURO

UNITED KINGDOM

• London

Link to trial result